Medication Management Among Individuals With Neurodevelopmental Disabilities

NCT03121651 | Completed

• 2 other identifiers: HUM00107874 and HUM0013926790RE5012
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to develop a reinforcement learning (RL)-adaptive visual and interactive support application (hereafter RL-adaptive support) to help young adults with spina bifida or cerebral palsy become more independent with medication management. Individuals with disabilities who are empowered to manage several aspects of their lives can ultimately be better integrated into and contribute more to society.

Conditions

Spina Bifida; Cerebral Palsy

Keywords

Mobile technology; Reinforcement-learning; Medication management

Outcome Measures

Primary Outcomes (1)

• Prefer to continue to use RL-adaptive support after study is over

  Qualitative feedback

  at least 18 weeks after beginning study

Secondary Outcomes (3)

• Usefulness of the aspects of the RL-adaptive support

  End of each phase, which lasts approximately 6 weeks

• Most and least helpful aspects of RL-adaptive support application

  End of each phase, which lasts approximately 6 weeks

• Ease of use of RL-adaptive support application

  End of each phase, which lasts approximately 6 weeks

Study Arms (1)

RL-adaptive application

EXPERIMENTAL

Dyad is comprised of individual with disability (spina bifida or cerebral palsy) and the respective parent/legal guardian (also referred to as caregivers). Young adult will use the RL-adaptive support application that the investigators are developing to help manage medications.

Device: RL-adaptive application

Interventions

RL-adaptive application DEVICE

Up to 6 dyads of individuals with disabilities and their caregivers will be recruited to collaborate in defining the features and content of the RL-adaptive support. The steps in developing the RL-adaptive support include having the dyads use for approximately 6 weeks each: 1. young adult uses an electronic medication pillbox that sends its pillbox openings within one hour of opening to the research team, 2. young adult uses the electronic medication pillbox + both use a commercially available medication reminder app + caregiver uses a pillbox opening notification app, and 3. young adult uses the electronic medication pillbox + the RL-adaptive support including push notifications in the form of text messages + caregiver uses the pillbox opening notification app. The goal is to reduce the number of caregiver prompts necessary for the medication pillbox to be opened.

RL-adaptive application

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For young adult:
• Diagnosed with cerebral palsy or spina bifida and previously enrolled in HUM00081812
• Age 18-26 years-old
• Having mild-moderate cognition based on consultation with the investigators and the results of the following tests: iBRIEF Metacognition index T-Score, CVLT List A Free Recall T Score, ReyO Organization T-Score, PPVT Scaled Score, Tower Scaled Score, TRAQ question 4: Do participants take medications correctly and on their own?
• Having adequate physical dexterity (to be able to open a pill box and use an iPad/tablet)
• Taking two or more routine oral medicines in pill formulation
• Being able to take capsules or tablets
• Still living at home with their parent/legal guardian
• Have Wi-Fi/Internet access at home
• For parent/caregiver:
• Being the parent/legal guardian of a person with aforementioned disability
• Owning a cell phone
• Have Wi-Fi/Internet access at home

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Spinal Dysraphism; Cerebral Palsy

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Study Officials

• Karen B Farris, PhD

  Professor and Chair, Department of Clinical Pharmacy, University of Michigan College of Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Charles R. Walgreen III Professor of Pharmacy Administration

Model Details: Unblinded pilot study with 1 intervention arm

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 20, 2017
• Study Start: November 11, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 2, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)